Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201809487841211 Date of Registration: 12/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Dynamic Limit of Stability and Ankle Joint Function Following Neuromuscular Training of Unstable Ankle Joints
Official scientific title Dynamic Limit of Stability and Ankle Joint Function Following Neuromuscular Training of Unstable Ankle Joints
Brief summary describing the background and objectives of the trial This study investigated and correlated between the dynamic limit of stability and functional level of the ankle joint in patients with unilateral chronic ankle instability after receiving dynamic neuromuscular training.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/12/2010
Actual trial start date 12/01/2011
Anticipated date of last follow up 15/08/2011
Actual Last follow-up date 15/10/2011
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Completed
Publication URL not published
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Neuromuscular Training 5 days per week 4 weeks neuromuscular training program emphasizes postural control and progressive challenges to the sensory motor system to restore normal motor programs in patients with chronic musculoskeletal disorder. Subjects progress through static, dynamic, and functional phases using simple rehabilitation tools (Janda & VaVrova, 2001 and Page, 2006) which challenged their balance capabilities. 20
Control Group no intervention 4 weeks no intervention 20 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Subjects with unilateral FAI. 2. All subjects completed a questionnaire by self-report to be characterized as having FAI . Subjects were satisfying the following criteria:  Experienced at least one significant lateral ankle sprain of either the right or left ankle, but not both within the last year.  Suffered at least one repeated injury or the experience of a feeling of instability or ‘‘giving way in either the right or left ankle.  Not undergoing any formal or informal rehabilitation of the unstable ankle. 3. All subjects with positive single-leg standing test 4. The uninvolved limb had no history of ankle inversion sprain or lower extremity pathology, including fracture or arthritis. In addition, the passive and active ranges of inversion, eversion, plantar-flexion, and dorsiflexion were painless. 1. Ankle joint pain, joint swelling, any rheumatologic disorders, or any systemic disease that might interfere with sensory input. 2. Ankle surgery in either leg. 3. Gross limitation in ankle range of motion. 4. Lower extremity injury other than lateral ankle sprain in past 12 weeks. 5. Any joint disease or bony fracture in the lower extremity. 6. History of neurological disorder affecting the upper or lower extremities, vestibular dysfunction, or balance disorder Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s) 18 Year(s) 25 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/09/2018 instituational review board
Ethics Committee Address
Street address City Postal code Country
7 Ahmed El Zaiat Street, Bien El Sarayat, Giza Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Limit of stability at baseline and after 4 weeks of training
Secondary Outcome functional joint stability level at baseline and after 4 weeks of training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy cairo university 7 Ahmed El Zaiat Street, Bien El Sarayat, Giza Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor faculty of physical therapy cairo university Giza Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abeer Ramadan Ibrahim faculty of physical therapy, cairo university Giza 12612 Egypt
Amira abdallah Abd El Megeid faculty of physical therapy , cairo univerasity Giza 12612 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator abeer ibrahim abeerramadan@hotmail.com 00201223821020 faculty of physical therapy, cairo university
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant professor in faculty of physical therapy cairo university
Role Name Email Phone Street address
Public Enquiries abeer ibrahim abeerramadan@hotmail.com 00201223821020 faculty of physical therapy, cairo university
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant professor faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries Abeer Ibrahim abeerramadan@hotmail.com 00201223821020 faculty of physical therapy , cairo university
City Postal code Country Position/Affiliation
Giza 12612 Egypt assistant professor in faculty of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes Mixed Design MANOVA revealed that the dynamic limit of stability test duration decreased and the AJFAT score increased significantly in Group A after training compared with before (p=0.000). Similarly, the dynamic limit of stability test duration decreased and the AJFAT score increased significantly in Group A compared with Group B after training (p=0.000). Pearson correlation showed significant strong negative correlation between the dynamic limit of stability test duration and AJFAT score in Group A (r=-0.647, p=0.000). 28/11/2017 27/04/2018
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.oarsijournal.com/article/S1063-4584(18)30861-6/fulltext
Changes to trial information